Soothe And Cool Treat

Product NDC: 53329-080
11-digit product format: 533290080
Labeler code: 53329
Product ID: 53329-080_e9c0d6a1-f897-61ae-e053-2995a90aeabc
Type: HUMAN OTC DRUG
Nonproprietary name: Miconazole Nitrate
Dosage form: CREAM
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M005
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2007-01-01
Marketing end: 0000-00-00
Substance: MICONAZOLE NITRATE
Active strength: 20 mg/100g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-080		D	Discontinued by firm	2026-10-05
excluded product	product	53329-080		D	Discontinued by firm	2026-10-05
excluded package	package	53329-080	53329-080-57	D	Discontinued by firm	2026-10-05
excluded package	package	53329-080	53329-080-58	D	Discontinued by firm	2026-10-05
excluded package	package	53329-080	53329-080-57	D	Discontinued by firm	2026-10-05
excluded package	package	53329-080	53329-080-58	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 54 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-080-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-080-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-080-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-080-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-080-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-080-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-080-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-080-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-080-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-080-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-080-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-080-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-080-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-080-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-080-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-080-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-080-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-080-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-080-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-080-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-080-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-080-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-080-57	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-080-57	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-080-58	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-080-57	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-080-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-080-57	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-080-58	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-080-57	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-080-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-080-57	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-080-58	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-080-57	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-080-58	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53329-080-57	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-080-57	GM - Gram	53329-080	dd3c27b5-d2dd-4678-b9ef-191b3976fd37	1	2012-07-24
53329-080-58	GM - Gram	53329-080	67d5c4bd-053a-418b-83a8-efdce3b4539b	1	2012-07-24

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REINREUDE MULTI-PURPOSE TREATMENT	TOLNAFTATE 1% MULTI-PURPOSE TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a380945-9235-783a-e063-6294a90a094d	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH Multi-Purpose Nail Solution	TOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTION	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4af770-2bba-52a8-e063-6294a90ac287	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH Clotrimazole	CLOTRIMAZOLE1% CLOTRIMAZOLE	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4b304a-1acc-9185-e063-6394a90a1176	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH FUNGI NAIL	TOLNAFTATE 1% FUNGI NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c6b7a-3c3e-1510-e063-6294a90a409a	2026-07-21	Warnings	Exact identifier application number: M005
SERYNTH HELPS WITH FUNGAL NAIL	TOLNAFTATE 1% HELPS WITH FUNGAL NAIL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c9ad1-e652-2b3b-e063-6394a90a2935	2026-07-21	Warnings	Exact identifier application number: M005
DERMFREE HELPS WITH NAGELPILZ	TOLNAFTATE 1% HELPS WITH NAGELPILZ	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d9361-3633-59b2-e063-6294a90aa3ea	2026-07-21	Warnings	Exact identifier application number: M005
OURUI ONE FUNGAL NAIL TREATMENT	TOLNAFTATE 1% FUNGAL NAIL TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a473f03-f4cc-74ef-e063-6394a90ac707	2026-07-20	Warnings	Exact identifier application number: M005
AVENASTER FUNGAL NAIL CARE DUO SET (NIGHT)	UNDECYLENIC ACID 25% FUNGAL NAIL CARE DUO SET (NIGHT)	Jiangxi Yudexi Pharmaceutical Co., LTD	51eb8766-cc94-360d-e063-6294a90a6953	2026-07-20	Warnings	Exact identifier application number: M005
TINGOLE FUNGAL NAIL Patches	TOLNAFTATE 1% FUNGAL NAIL PATCHES	Jiangxi Yudexi Pharmaceutical Co., LTD	5272c6fa-75f7-c698-e063-6394a90ac81e	2026-07-20	Warnings	Exact identifier application number: M005
Vamy ANTIFUNGAL	TOLNAFTATE 1% ANTIFUNGAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4dfdf3a2-95a8-9176-e063-6294a90a64de	2026-07-20	Warnings	Exact identifier application number: M005
Antifungal cream	ANTIFUNGAL CREAM	Shenzhen Earth Surface Trading Co., Ltd.	5708cc16-9a26-fd3c-e063-6394a90ac0ee	2026-07-20	Warnings	Exact identifier application number: M005
TrpWinner TOENAIL FUNGUS PEN	UNDECYLENIC ACID 25% TOENAIL FUNGUS PEN	Jiangxi Yudexi Pharmaceutical Co., LTD	523c2a9c-3b35-bf73-e063-6394a90ae17d	2026-07-20	Warnings	Exact identifier application number: M005
Charmpoo Antifungal Cream	MICONAZOLE NITRATE 2% ANTIFUNGAL CREAM	Jiangxi Yudexi Pharmaceutical Co., LTD	4ac347b5-d21b-cc9a-e063-6394a90a5496	2026-07-20	Warnings	Exact identifier application number: M005
Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGAL	CLOTRIMAZOLE 1% TINEA VERSICOLOR TREATMENT ANTIFUNGAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4ac31b1d-59d7-f45c-e063-6294a90a0d3d	2026-07-20	Warnings	Exact identifier application number: M005
IraEvanes ANTIFUNGAL FOOT	TOLNAFTATE 1% ANTIFUNGAL FOOT	Jiangxi Yudexi Pharmaceutical Co., LTD	4d851a99-a453-e829-e063-6294a90a9118	2026-07-20	Warnings	Exact identifier application number: M005
LYSSERA Fungal Nail Renewal	UNDECYLENIC ACID 25% ANTIFUNGA	Jiangxi Yudexi Pharmaceutical Co., LTD	4dea6df4-e66b-c24a-e063-6294a90afca7	2026-07-20	Warnings	Exact identifier application number: M005
Kakalsa TOENAIL FUNGUS TREATMENT	UNDECYLENIC ACID 25% TOENAIL FUNGUS TREATMENT	Jiangxi Yudexi Pharmaceutical Co., LTD	5123c0c3-bba8-d61c-e063-6394a90aab70	2026-07-20	Warnings	Exact identifier application number: M005
SOVS FUNGAL NAIL REPAIR RENEWAL	UNDECYLENIC ACID 25% FUNGAL NAIL REPAIR RENEWAL	Jiangxi Yudexi Pharmaceutical Co., LTD	536b0c48-691e-755b-e063-6294a90a778e	2026-07-20	Warnings	Exact identifier application number: M005
Tea Tree Antifungal	CLOTRIMAZOLE	HONG KONG UNORDERED TRADING CO., LIMITED	56de35b7-b57d-1c62-e063-6294a90a757d	2026-07-18	Warnings	Exact identifier application number: M005
ACTIV-CHARCOAL ANTIFUNGAL	TOLNAFTATE	HONG KONG UNORDERED TRADING CO., LIMITED	56def103-40ef-cd88-e063-6394a90a0717	2026-07-18	Warnings	Exact identifier application number: M005

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VW4H1CYW1K	MICONAZOLE NITRATE	22832-87-7	MICONAZOLE NITRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-080-57	53329008057	141 g in 1 TUBE (53329-080-57)	141 g	2007-01-01	0000-00-00	No	No	Current
53329-080-58	53329008058	56 g in 1 TUBE (53329-080-58)	56 g	2007-01-01	0000-00-00	No	No	Current